Trial Outcomes & Findings for Perclose Multi-Access Duplex Ultrasound (DUS) Study (NCT NCT04904809)

Last Updated: 2023-07-20

Results Overview

Vascular complications detected by scheduled DUS at discharge in subjects with asymptomatic/non-visible complications. Major complications are defined as those which require surgical, interventional, or pre-specified repair and/or hospitalization.

Recruitment status

COMPLETED

Study phase

Target enrollment

36 participants

Primary outcome timeframe

Within 24 hours of procedure.

Results posted on

2023-07-20

Participant Flow

A total of 36 subjects will be registered at 2 US investigational sites. All subjects must have femoral duplex ultrasound (DUS) at discharge and at a 30-dayfollow-up visit (if any access site-related vascular complications(either symptomatic/visible or asymptomatic/nonvisible), nerve injury, or infection at discharge, by either the investigator or the core laboratory).

Participant milestones

Participant milestones
Measure	All Registered Patients All registered patients will have multiple access sites in a single vein closed utilizing the Perclose ProGlide suture-mediated closure (SMC) System and/or Perclose ProStyle suture-mediated closure and repair (SMCR) System. Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System: The Perclose ProGlide SMC and Perclose ProStyle SMCR in this study will be used for multiple access site closures in a single vein in the ablation procedure.
Overall Study STARTED	36
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Perclose Multi-Access Duplex Ultrasound (DUS) Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Registered Patients n=36 Participants All registered patients will have multiple access sites in a single vein closed utilizing the Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System. Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System: The Perclose ProGlide SMC and Perclose ProStyle SMCR in this study will be used for multiple access site closures in a single vein in the ablation procedure.
Age, Continuous	62.9 Years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Arrhythmia Paroxysmal AF	17 Participants n=5 Participants
Arrhythmia Persistent AF	11 Participants n=5 Participants
Arrhythmia Atrial Flutter	6 Participants n=5 Participants
Arrhythmia Other	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 24 hours of procedure.

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Outcome measures

Outcome measures
Measure	All Registered Patients n=32 Participants All registered patients will have multiple access sites in a single vein closed utilizing the Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System. Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System: The Perclose ProGlide SMC and Perclose ProStyle SMCR in this study will be used for multiple access site closures in a single vein in the ablation procedure.
Number of Subjects With Major Vascular Complications by DUS Detection at Discharge Femoral Vein Stenosis (> 50%) Development at the Puncture	0 Participants
Number of Subjects With Major Vascular Complications by DUS Detection at Discharge Deep Vein Thrombosis in the Target Limb	0 Participants
Number of Subjects With Major Vascular Complications by DUS Detection at Discharge Hematoma	0 Participants
Number of Subjects With Major Vascular Complications by DUS Detection at Discharge Pseudoaneurysm	0 Participants
Number of Subjects With Major Vascular Complications by DUS Detection at Discharge Requiring Surgical or Percutaneous Repair	0 Participants
Number of Subjects With Major Vascular Complications by DUS Detection at Discharge Requiring Thrombin Injection, Fibrin Adhesive Injection, or Ultrasound-guided Compression	0 Participants
Number of Subjects With Major Vascular Complications by DUS Detection at Discharge Arteriovenous (AV) Fistula	0 Participants
Number of Subjects With Major Vascular Complications by DUS Detection at Discharge Venous Tear	0 Participants
Number of Subjects With Major Vascular Complications by DUS Detection at Discharge Venous Perforation	0 Participants
Number of Subjects With Major Vascular Complications by DUS Detection at Discharge Arterial Tear	0 Participants
Number of Subjects With Major Vascular Complications by DUS Detection at Discharge Arterial Perforation	0 Participants
Number of Subjects With Major Vascular Complications by DUS Detection at Discharge Other Vascular Complication	0 Participants
Number of Subjects With Major Vascular Complications by DUS Detection at Discharge Arterial Stenosis	0 Participants
Number of Subjects With Major Vascular Complications by DUS Detection at Discharge Arterial Dissection	0 Participants
Number of Subjects With Major Vascular Complications by DUS Detection at Discharge Mobile Perclose Common Femoral Vein	0 Participants

PRIMARY outcome

Timeframe: Within 24 hours of procedure.

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Vascular complications detected by scheduled DUS at discharge in subjects with asymptomatic/non-visible complications. All complications other than Major complications are considered to be minor complications.

Outcome measures

Outcome measures
Measure	All Registered Patients n=32 Participants All registered patients will have multiple access sites in a single vein closed utilizing the Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System. Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System: The Perclose ProGlide SMC and Perclose ProStyle SMCR in this study will be used for multiple access site closures in a single vein in the ablation procedure.
Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge Femoral Vein Stenosis (> 50%) Development at the Puncture Site related to Closure Techniqu	0 Participants
Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge Deep Vein Thrombosis in the Target Limb	3 Participants
Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge Hematoma	1 Participants
Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge Pseudoaneurysm	0 Participants
Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge Arteriovenous (AV) Fistula	0 Participants
Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge Venous Tear	0 Participants
Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge Venous Perforation	0 Participants
Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge Arterial Tear	0 Participants
Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge Arterial Perforation	0 Participants
Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge Other Vascular Complication	1 Participants
Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge Arterial Stenosis	0 Participants
Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge Arterial Dissection	0 Participants
Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge Mobile Perclose Common Femoral Vein	1 Participants

Adverse Events

All Registered Patients

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Registered Patients n=36 participants at risk All registered patients will have multiple access sites in a single vein closed utilizing the Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System. Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System: The Perclose ProGlide SMC and Perclose ProStyle SMCR in this study will be used for multiple access site closures in a single vein in the ablation procedure.
Gastrointestinal disorders Oesophagitis	2.8% 1/36 • 30 days The data reported/presented under Outcome Measure 2 is a list of "vascular complications", whereas data reported under "Other (Not Including Serious) Adverse Events" section is a list of adverse events. In this study, there was 1 subject with deep vein thrombosis (DVT) that was identified by the site, reported as adverse event, and adjudicated by the CEC. In addition, there were 2 subjects that had DVT identified by the DUS core lab but not identified by the site.

Other adverse events

Other adverse events
Measure	All Registered Patients n=36 participants at risk All registered patients will have multiple access sites in a single vein closed utilizing the Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System. Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System: The Perclose ProGlide SMC and Perclose ProStyle SMCR in this study will be used for multiple access site closures in a single vein in the ablation procedure.
Injury, poisoning and procedural complications Vascular Access	2.8% 1/36 • 30 days The data reported/presented under Outcome Measure 2 is a list of "vascular complications", whereas data reported under "Other (Not Including Serious) Adverse Events" section is a list of adverse events. In this study, there was 1 subject with deep vein thrombosis (DVT) that was identified by the site, reported as adverse event, and adjudicated by the CEC. In addition, there were 2 subjects that had DVT identified by the DUS core lab but not identified by the site.
Injury, poisoning and procedural complications Site Haemorrhage	2.8% 1/36 • 30 days The data reported/presented under Outcome Measure 2 is a list of "vascular complications", whereas data reported under "Other (Not Including Serious) Adverse Events" section is a list of adverse events. In this study, there was 1 subject with deep vein thrombosis (DVT) that was identified by the site, reported as adverse event, and adjudicated by the CEC. In addition, there were 2 subjects that had DVT identified by the DUS core lab but not identified by the site.
Vascular disorders Deep Vein Thrombosis	2.8% 1/36 • 30 days The data reported/presented under Outcome Measure 2 is a list of "vascular complications", whereas data reported under "Other (Not Including Serious) Adverse Events" section is a list of adverse events. In this study, there was 1 subject with deep vein thrombosis (DVT) that was identified by the site, reported as adverse event, and adjudicated by the CEC. In addition, there were 2 subjects that had DVT identified by the DUS core lab but not identified by the site.
Vascular disorders Thrombosis	2.8% 1/36 • 30 days The data reported/presented under Outcome Measure 2 is a list of "vascular complications", whereas data reported under "Other (Not Including Serious) Adverse Events" section is a list of adverse events. In this study, there was 1 subject with deep vein thrombosis (DVT) that was identified by the site, reported as adverse event, and adjudicated by the CEC. In addition, there were 2 subjects that had DVT identified by the DUS core lab but not identified by the site.
Vascular disorders Venous Haemorrhage	2.8% 1/36 • 30 days The data reported/presented under Outcome Measure 2 is a list of "vascular complications", whereas data reported under "Other (Not Including Serious) Adverse Events" section is a list of adverse events. In this study, there was 1 subject with deep vein thrombosis (DVT) that was identified by the site, reported as adverse event, and adjudicated by the CEC. In addition, there were 2 subjects that had DVT identified by the DUS core lab but not identified by the site.

Additional Information

Sandeep Pingle

Abbott Vascular

Phone: 858-222-9673

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place